Own-check is regulated in the Food Act (297/2021, 15 §). Obligation for own-check applies to all food business operators, importers, manufacturers, and marketers, with a few exceptions. The local food authority monitors that own-check includes the essentials to ensure compliance of food supplements at all stages of the product, and that own-check is implemented in practice.
Own-check in accordance with the Food Act obliges a food business operator to have sufficient and correct information on food supplements that they produce, manufacture, import, export, package, market, serve or donate for food. The product must be safe and must not mislead the consumer.The compliance of the products can be monitored under own-check through, among other things, certificates, inspections and/or own-check samples and analysis from raw material suppliers.
Own-check of food supplements should include at least the following:
Composition:
- only authorised vitamins, minerals and compounds of them are used in the food supplement
- the history of use of the food supplement ingredients as food prior to May 1997 has been verified and the food supplement does not contain novel food ingredients that are not authorised in EU
- the authorised novel food ingredients contained in the food supplement meet the conditions of use set for them
- raw materials do not contain hormones or doping substances or any other prohibited substances
- only authorised additives, flavourings and enzymes are used and their conditions for use are met
- the microbiological quality of raw materials and finished food supplements is good
- food supplements and their raw materials do not contain contaminants exceeding the permitted maximum amounts
- the raw materials of food supplements do not contain pesticide residues in excess of the permitted maximum amounts
Medicinal product vs food supplement
The food supplement is not classified as a medicine within the meaning of section 3 of the Medicines Act (395/87). If a food business operator intends to place on the market a food supplement containing substances or herbals listed in the List of Medicines, The Finnish Food Authority recommends that the operator contact Fimea to assess the need for classification. Fimea may also classify a product as a medicine on its own initiative if it meets the criteria for the medicine. The list of medicines can be found on Fimea's website.
Organic
If food supplements are sold as organic products (organic, biodynamic, eco, etc.), the product must fulfil the requirements of the EU Regulation on organic production, and the labelling must show that the product comes under organic control, i.e. the emblem of the organic controller.
Genetic modification
Any genetically modified organisms used in the production of the food supplement and ingredients of the food supplement manufactured from such organisms are indicated on labelling and traceability has been ensured (Regulations (EC) 1829/2003 and (EC) 1830/2003).
Irradiation
Any irradiation of dried spice herbs, spices and spice plants must be declared on the labelling in accordance with regulations. (Note that the irradiation of any other ingredients is not allowed, under the Decree of the Ministry of Trade and Industry on Treatment of Food with Ionizing Radiation, 852/2000).
Package labelling:
- is prepared correctly and mandatory food information is also provided correctly in distance selling,
- is in Finnish and Swedish,
- is easily visible and readable,
- correspond to the composition
- includes possible restrictions of use and warnings have been made taking into account potential risk groups, if necessary
Marketing
Marketing of food supplement is in accordance with regulations and good practice. The claims made about the food supplement are true and are not medicinal.
Traceability
The traceability of food supplements can be verified on the basis of documents (e.g. supplier’s shipping lists, invoices or other stock records). The food supplements sold must also be traceable if they have been delivered other than directly to the consumer.
Withdrawals and adverse effect reports
Own-check must include procedures for any product withdrawals or adverse effect reports required.
Notifications
The food supplement business has been notified to the food control authority of your municipality no later than four weeks before the start of operations.
The food supplement has been notified to the Finnish Food Authority, it is up-to-date and can be verified by inspection upon request
Read more about own-check in the Food Supplement Guide (paragraph 7.1).